VALUMEDS ASPIRIN FREE HEADACHE RELIEF PM
Medically reviewed by Drugs.com. Last updated on Apr 11, 2018.
Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 500mg, DIPHENHYDRAMINE CITRATE 38mg
Labeler: SPIRIT PHARMACEUTICALS LLC
NDC Code: 68210-2000
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
|Active ingredients (in each caplet)||Purpose|
|Acetaminophen 500 mg||Pain reliever|
|Diphenhydramine citrate 38 mg||Nighttime sleep-aid|
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 2 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- avoid alcoholic drinks
- drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
- any new symptoms occur
- sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
- pain gets worse or lasts more than 10 days
- painful area is red or swollen
- fever gets worse or lasts more than 3 days
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
- do not use more than directed
- do not use in children under 12 years of age
- adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
- store at controlled room temperature 20°-25°C (68°-77°F)
- read all product information before using. Keep this box for important information.
colloidal silicon dioxide, FD&C Blue # 1, FD&C blue #2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, titanium dioxide
SPIRIT PHARMACEUTICALS, LLC.
RONKONKOMA, NY 11779
|VALUMEDS ASPIRIN FREE HEADACHE RELIEF PM
acetaminophen and diphenhydramine citrate tablet, coated
|Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)|
|ELYSIUM PHARMACEUTICALS LIMITED||915664486||manufacture(68210-2000)|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.